A phase IB trial of 24-hour intravenous PX-12, a thioredoxin-1 inhibitor, in patients with advanced gastrointestinal cancers
Open accessAbstract
We investigated the safety, pharmacokinetics, and pharmacodynamics of PX-12, a thioredoxin-1 (Trx-1) inhibitor, administered as a 24-hour infusion every 7 or 14 days in patients with gastrointestinal malignancies. PX-12 is the first Trx-1 inhibitor to undergo clinical development. The first Phase 1 study of PX-12 demonstrated promising clinical activity, but the 1 and 3 hour-infusion schedules investigated were associated with a strong and irritating odor due to exhalation of one of its metabolites, 2-butanethiol. In an effort to achieve tolerability and achieve a drug exposure level necessary for biological activity, the current study was undertaken. While the maximally tolerated dose was estimated to be 300 mg/m(2) /24 h once a week as the 2-butanethiol expirate was tolerable at that dose level, no evidence of clinical activity was observed. Pharmacokinetic studies of the parent compound PX-12 demonstrated rapid, irreversible binding to plasma components, resulting in low (ng/ml) peak plasma concentrations of non-bound PX-12 during infusion. DCE-MRI was performed pre-and post-infusion in three patients. There were no significant trends observed in changes in plasma Trx-1, vascular endothelial growth factor (VEGF), or beta fibroblast growth factor (FGF-2) pre- or post-treatment. However, there was a trend for a decrease in circulating Trx-1 during the first four PX-12 treatment cycles in patients that had a Trx-1 baseline level >18 ng/mL. Aggregate clinical trial results suggest that further clinical development of PX-12, as an intravenous infusion, is not feasible. However, the Trx-1 pathway remains a target of interest in patients with gastrointestinal malignancies.
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Clinical evaluation of PX-12 failed to demonstrate beneficial effects on VEGF suppression or tumor progression.
“clinical evaluation of PX-12 failed to demonstrate beneficial effects on VEGF suppression or tumor progression [359,360]”
From HIF inhibition: Current strategies and clinical challenges (2026) · cites this paper as [360]
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- Authors
- Baker, A. F., Adab, K. N., Raghunand, N., Chow, H. H. S., Stratton, S. P., Squire, S. W., Boice, M., Pestano, L. A., Kirkpatrick, D. L., & Dragovich, T.
- Affiliations
- Banner MD Anderson Cancer Center (US)
- Corresponding author
- Dragovich, T.
- Venue
- Investigational New Drugs
- Published
- 2012-06-19
- Volume
- 31
- Issue
- 3
- Pages
- 631-641
- ISSN
- 0167-6997 (ISSN-L)
- 1573-0646
- PMC
- PMC3988981
- OpenAlex
- W2013933294
- Cited by
- 52
- References
- 31
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 3 · 2023: 2 · 2022: 3 · 2021: 3 · 2020: 6 · 2019: 7 · 2018: 1 · 2017: 5 · 2016: 5 · 2015: 6 · 2014: 4 · 2013: 3
- FWCI
- 1.67
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- Locations
- Investigational New Drugs (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Cancer Institute (P50 CA95060, P01CA017094, P50CA095060, P30CA023074)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Redox biology and oxidative stress
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Gastric Cancer Management and Outcomes
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Glutathione Transferases and Polymorphisms
- Keywords
- PX-12, gastrointestinal cancer, pharmacokinetics, pharmacodynamics, plasma protein binding, maximum tolerated dose, DCE-MRI, vascular endothelial growth factor, fibroblast growth factor 2, drug tolerability
- MeSH terms
- Aged, Antineoplastic Agents, Disulfides, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Gastrointestinal Neoplasms, Humans, Imidazoles, Infusions, Intravenous, Male, Middle Aged, Radiography, Thioredoxins, Fibroblast Growth Factor 2, Maximum Tolerated Dose, Vascular Endothelial Growth Factor A
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